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510(k) Data Aggregation

    K Number
    K201113
    Device Name
    Resascope RS-01/B
    Date Cleared
    2020-12-21

    (238 days)

    Product Code
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Advanced Medical Systems Group SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    When used with a fibreoptic endoscope, Resascope is a video guided catheter intended to be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications
    Device Description
    The Resascope video guided catheter can be used in the lumbar and sacral epidural space to view the epidural anatomy, the pathology and to deliver approved drugs for epidural administration. It can also be used by physicians to light and view the tissues in the epidural space of the lumbar and sacral spine, and in order to assist in the diagnosis of related pathologies, using a percutaneous approach through the sacral hiatus. It is designed to be used by trained medical staff for less than 60 minutes usage time period. lt is design with a soft tip and the addition of some blocks inside that allow the catheter to remain locked and therefore oriented, without return to zero. The medical device is basically structured by two parts: the orientable catheter, intended to enter the peridural space, and the knob, to be used for the orientation of the catheter tip (tip flexion); on the knob there are connection tubes for inserting the endoscope and for connection to the infusion sets.
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